Concise Review: A Comprehensive Analysis of Reported Adverse Events in Patients Receiving Unproven Stem Cell-Based Interventions

Overview

Journal Stem Cells Transl Med

Publisher Oxford University Press

Specialties Cell Biology
Pharmacology

Date 2018 Aug 1

PMID 30063299

Citations 63

Authors

Gerhard Bauer

Magdi Elsallab

Mohamed Abou-El-Enein

Affiliations

Soon will be listed here.

Abstract

The promise of stem cell (SC) therapies to restore functions of damaged tissues and organs brings enormous hope to patients, their families, loved ones, and caregivers. However, limits may exist for which indications SC therapies might be useful, efficacious, and safe. Applications of innovative therapies within regulatory boundaries and within the framework of controlled clinical trials are the norm in the scientific and medical community; such a system minimizes patient risk by setting a clear and acceptable safety and efficacy profile for new therapeutics before marketing authorization. This careful clinical validation approach often takes time, which patients suffering from terminal or debilitating diseases do not have. Not validated, unproven stem cell interventions (SCI) that promise a working treatment or cure for severe diseases have therefore found their way into the patient community, and providers of such treatments often take advantage of the public's willingness to pay large amounts of money for the misguided hope of a reliable recovery from their illnesses. We conducted a review of scientific publications, clinical case reports, and mass media publications to assess the reported cases and safety incidents associated with unproven SCI. The review also analyzes the main factors that were identified as contributing to the emergence and global rise of the "stem cell tourism" phenomenon. Stem Cells Translational Medicine 2018;1-10.

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References

Saha K, Jaenisch R . Technical challenges in using human induced pluripotent stem cells to model disease. Cell Stem Cell. 2009; 5(6):584-95. PMC: 2921621. DOI: 10.1016/j.stem.2009.11.009. View

Matthews K, Iltis A . Unproven stem cell-based interventions and achieving a compromise policy among the multiple stakeholders. BMC Med Ethics. 2015; 16(1):75. PMC: 4634187. DOI: 10.1186/s12910-015-0069-x. View

Alderazi Y, Coons S, Chapman K . Catastrophic demyelinating encephalomyelitis after intrathecal and intravenous stem cell transplantation in a patient with multiple sclerosis. J Child Neurol. 2011; 27(5):632-5. DOI: 10.1177/0883073811422831. View

Lodi D, Iannitti T, Palmieri B . Stem cells in clinical practice: applications and warnings. J Exp Clin Cancer Res. 2011; 30:9. PMC: 3033847. DOI: 10.1186/1756-9966-30-9. View

Ikonomou L, Freishtat R, Wagner D, Panoskaltsis-Mortari A, Weiss D . The Global Emergence of Unregulated Stem Cell Treatments for Respiratory Diseases. Professional Societies Need to Act. Ann Am Thorac Soc. 2016; 13(8):1205-7. DOI: 10.1513/AnnalsATS.201604-277ED. View

Horner C, Tenenbaum E, Sipp D, Master Z . Can civil lawsuits stem the tide of direct-to-consumer marketing of unproven stem cell interventions. NPJ Regen Med. 2018; 3:5. PMC: 5818472. DOI: 10.1038/s41536-018-0043-6. View

Sipp D . Direct-to-consumer stem cell marketing and regulatory responses. Stem Cells Transl Med. 2013; 2(9):638-40. PMC: 3754464. DOI: 10.5966/sctm.2013-0040. View

Regenberg A, Hutchinson L, Schanker B, Mathews D . Medicine on the fringe: stem cell-based interventions in advance of evidence. Stem Cells. 2009; 27(9):2312-9. DOI: 10.1002/stem.132. View

Knoepfler P . From bench to FDA to bedside: US regulatory trends for new stem cell therapies. Adv Drug Deliv Rev. 2014; 82-83:192-6. PMC: 4398607. DOI: 10.1016/j.addr.2014.12.001. View

10.

Caulfield T, Sipp D, Murry C, Daley G, Kimmelman J . SCIENTIFIC COMMUNITY. Confronting stem cell hype. Science. 2016; 352(6287):776-7. DOI: 10.1126/science.aaf4620. View

11.

Lo B, Parham L . Ethical issues in stem cell research. Endocr Rev. 2009; 30(3):204-13. PMC: 2726839. DOI: 10.1210/er.2008-0031. View

12.

Arango-Rodriguez M, Ezquer F, Ezquer M, Conget P . Could cancer and infection be adverse effects of mesenchymal stromal cell therapy?. World J Stem Cells. 2015; 7(2):408-17. PMC: 4369496. DOI: 10.4252/wjsc.v7.i2.408. View

13.

Marks P, Gottlieb S . Balancing Safety and Innovation for Cell-Based Regenerative Medicine. N Engl J Med. 2018; 378(10):954-959. DOI: 10.1056/NEJMsr1715626. View

14.

Kuriyan A, Albini T, Townsend J, Rodriguez M, Pandya H, Leonard 2nd R . Vision Loss after Intravitreal Injection of Autologous "Stem Cells" for AMD. N Engl J Med. 2017; 376(11):1047-1053. PMC: 5551890. DOI: 10.1056/NEJMoa1609583. View

15.

Taylor-Weiner H, Graff Zivin J . Medicine's Wild West--Unlicensed Stem-Cell Clinics in the United States. N Engl J Med. 2015; 373(11):985-7. DOI: 10.1056/NEJMp1504560. View

16.

Thirabanjasak D, Tantiwongse K, Thorner P . Angiomyeloproliferative lesions following autologous stem cell therapy. J Am Soc Nephrol. 2010; 21(7):1218-22. PMC: 3152236. DOI: 10.1681/ASN.2009111156. View

17.

Dlouhy B, Awe O, Rao R, Kirby P, Hitchon P . Autograft-derived spinal cord mass following olfactory mucosal cell transplantation in a spinal cord injury patient: Case report. J Neurosurg Spine. 2014; 21(4):618-22. DOI: 10.3171/2014.5.SPINE13992. View

18.

Berger I, Ahmad A, Bansal A, Kapoor T, Sipp D, Rasko J . Global Distribution of Businesses Marketing Stem Cell-Based Interventions. Cell Stem Cell. 2016; 19(2):158-162. DOI: 10.1016/j.stem.2016.07.015. View

19.

Knoepfler P, Turner L . The FDA and the US direct-to-consumer marketplace for stem cell interventions: a temporal analysis. Regen Med. 2018; 13(1):19-27. DOI: 10.2217/rme-2017-0115. View

20.

Ikka T, Fujita M, Yashiro Y, Ikegaya H . Recent Court Ruling in Japan Exemplifies Another Layer of Regulation for Regenerative Therapy. Cell Stem Cell. 2015; 17(5):507-8. DOI: 10.1016/j.stem.2015.10.008. View